|
Peritonitis (site of onset: cervix) [peritonitis] ([pyrexia], [abdominal pain]).Case narrative: initial information received on 29-mar-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 06-aug-2019 and transmitted to sanofi.This case involves a 33 years old female patient (160 cm and 54 kg) who experienced peritonitis (site of onset: cervix), while she was treated with with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].Data regarding this pregnancy were received prospectively, i.E.Before pregnancy outcome was known.The reported peritonitis (site of onset: cervix) occurred at 38 weeks of pregnancy the reported abdominal pain occurred at 38 weeks of pregnancy the reported pyrexia occurred at 38 weeks of pregnancy.The date of last menstrual period was not reported.The estimated due date was not reported.The actual date of delivery is (b)(6) 2018.The patient's past medical history included depression.The patient's past medical treatment included utemerin on (b)(6) 2018.The patient's past vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing obstructed labour, premature rupture of membranes, uterine hypotonus and anaemia, and was a non-tobacco user.Notes: outpatient background.Preoperative complications: none.Presence or absence of diabetes mellitus: none.History of surgery: none.Medical history: presence (depression).Smoking history: none.Concomitant medications included cefazolin sodium (cefamezin [cefazolin sodium]) for premature rupture of membranes; zolpidem tartrate (myslee) for product used for unknown indication; ampicillin sodium, sulbactam sodium (sulbactam-ampicillin) for infection prophylaxis; and olanzapine (zyprexa) for product used for unknown indication.Before surgery.Underlying disease: premature rupture of membranes, weak labour, obstructed labour, retal heart sounds abnormal.Patient condition: preoperative condition: generally healthy, nutritional state: good, radiotherapy: none.Date and method of surgery.It was not elective surgery.Method of surgery/method of reconstruction: caesarean section, suture of uterine musculature (heat treatment during surgery: none).Application of this product.Application site: anterior and posterior surfaces of the uterus (infection at the application site: presence).Direct application to the anastomosis site: presence, the number of the sheet: 2 sheets wrapping on the suture line of anastomosis part of intestinal tract: none application status: good, the operating surgeon's experience to use this product: presence.Status of the surgery: site of the placement of drain: none, kind of the drain: none presence or absence of pre-existing adhesion: none.In the abdominal cavity: pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: presence (0.5 l).Anastomosis of the resected parts.Presence or absence of the resected parts: none.Pre-existing non-purulent inflammation: none.Pre-existing infection: none.Suture thread (kind): inner layer (name: 1-vicry1)/external layer (name: 1-vicry1), absorbable, synthetic, and multi.Ligature (kind): absorbable and synthetic.Surgical field condition: contaminated operation (accidental contamination: membrane rupture, complete cervix dilatation).Suture of the laparotomy wound length of the laparotomy wound: 15 cm, suture layer: 3 layers.Suture method of the first layer (peritoneum): continuous suture, suture thread: absorbable and synthetic (name: 2-ovicry1).Suture method of the skin: manually sutured (knotted suture), suture thread: absorbable and synthetic (name: 4-opds).Pre-existing non-purulent inflammation: none, pre-existing infection: none.After surgery.Other concomitantly used medical devices: none.In case of the department of obstetrics and gynecology: presence (status: panperitonitis [mainly in the pelvis])..Tissue examination when foreign body reaction is diagnosed: none.Re-hospitalization for treatment: presence (date of re-hospitalization: (b)(6) 2018, date of discharge: (b)(6) 2018) re-laparotomy: presence (date of re-laparotomy: (b)(6) 2018, condition of this product: unknown (attachment of white film to around the uterus), removal of the product: it could not be removed, other measures: presence: intraperitoneal irrigation).On an unknown date, the patient got pregnant with oral clomid, hcg injection, and timing method at a clinic.On an unknown date, at 28 weeks pregnancy, the mouth of the uterus was closed, and the length of the cervix was 29.1 mm, and the patient was instructed to have rest without oral medicines.On (b)(6) 2018 (30w4d), the patient was transferred to another hospital to make a home visit.On (b)(6) 2018, the patient had been suffering from depression, sleeplessness, and inappetence since around (b)(6) 2018.On (b)(6) 2018, the patient wished to be managed at a hospital with department of psychiatry and was transferred to the reporter's hospital.The course was put under observation with drip infusion of utemerin.On (b)(6) 2018 (34w2d), the patient was discharged from the hospital because the condition was stable with oral medicines.Thereafter, the patient was followed up at the outpatient department.On (b)(6) 2018 (38w1d), the patient was hospitalized for premature rupture of membranes (prom).P0 the patient was hospitalized for prom.During the daytime, no contraction was induced.The patient followed a natural course and labor progressed.At 21:00, the cervical canal was completely dilated.Then, the labor gradually progressed.Variable deceleration with minimum heart rate of 90 bpm that recovered in about 30 seconds frequently occurred.At 23:00, the patient entered the labor room with physician a because of frequent variable deceleration.At 23:20, the engagement of head was poor, and vacuum extraction was decided.Physician b tried vacuum extraction twice, but no engagement of head was observed.Subsequently, physician a tried vacuum extraction 3 times, and perineal incision was performed.At the 3rd vacuum extraction by physician a, the cup slid and came off.The station of the fetal head remained unchanged, and obstructed labour due to cephalo-pelvic disproportion and decreased fetal heartbeat were diagnosed.At 23:30, grade a was declared, and it was decided to perform grade 1 extremely urgent caesarean section.At 23:33, physician b contacted the anesthesiologists, the pediatrics, and the operation room.At 23:40, an intravenous line was kept.At 23:45, the patient left the ward.At 23:48, the patient entered the operation room.At 23:53, the surgery was performed.At 23:54, the male infant was delivered with ap score of 8/9 and a weight of 3588 g.Then, the cervical canal was damaged when the fetal head was lifted from the abdominal cavity, and astriction with gauze was performed.The cervical canal was sutured.After delivery of the fetus, laceration of the posterior wall from the lower left side of the uterine body to the cervical canal was confirmed and was sutured with 1-0vicry1.Intraperitoneal irrigation with 500 ml of hot saline was performed.Before surgery, the marker for inflammation reaction was normal, and seprafilm was applied to the posterior wall, anterior wall, and abdominal wall.Bleeding: 2500 ml (including amnion fluid) blood transfusion in the operation room: rbc 6 u (o+ atypical 2ub+ was found, 4 u), ffp 4 u (ab+atypical) were administered.On (b)(6) 2018, delayed postoperative inflammatory reaction and pyrexia were observed.On (b)(6) 2018, pyrexia was observed.On (b)(6) 2018, the patient started taking an antibacterial drug.On (b)(6) 2018, the patient strongly wished to leave the hospital because of an improvement tendency of blood test values and the patient's mental burden and was discharged from the hospital on treatment with oral antibacterial drug.On (b)(6) 2018, the patient visited the hospital for pyrexia.After consultation with the patient, it was decided that the patient would receive antibacterial drug injection at the previous hospital.On (b)(6) 2018, the patient was re-admitted to the hospital for pyrexia and worsening of abdominal pain.Tv-us: the endometrium was thin, enlargement of the right adnexa of about 4 cm in the upper uterine segment was noted, and salpingitis was suspected.Tv-us: a small amount of ascites in the periphery of the liver and the border between the spleen and kidney and a small amount of ascites in the anterior surface of the uterus were observed.Abscess was unclear.Ct: loculated abscess in the upper uterine segment was suspected.The patient was admitted to the hospital and started receiving lvfx, an antibacterial drug.Peritonitis (development site was uterine cervix, the method of confirmation of the adverse event: ct) developed.On (b)(6) 2018, laparoscopic irrigation and drainage were performed for postoperative peritonitis.After surgery, the inflammation reaction and anaemia gradually improved.On (b)(6) 2018, the patient was discharged from the hospital.Various cultures failed to detect the causative bacteria.On (b)(6) 2018, the pyrexia, abdominal pain, and peritonitis (development site, uterine cervix) resolved.The patient developed an event of a serious peritonitis (site of onset: cervix) (peritonitis) 13 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant.The patient was hospitalized on the same day this event occurred.The patient was discharged on (b)(6) 2018 (hospitalization during 7 days).The patient developed an event of a serious pyrexia 4 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant.The patient was hospitalized 9 days after this event occurred.The patient was discharged on (b)(6) 2018 (hospitalization during 7 days).The patient developed an event of a serious abdominal pain 13 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant.The patient was hospitalized on the same day this event occurred.The patient was discharged on (b)(6) 2018 (hospitalization during 7 days).Relevant laboratory test results included: bacterial test - on (b)(6) 2018: [culture test: other (blood, cervix, and stool), target bacterial strain: e.Coli etc., bacteria detected: none]; on (b)(6) 2018: [culture test: other (blood, cervix, and stool), target bacterial strain: e.Coli etc., bacteria detected: none]; on (b)(6) 2018: [culture test: other (blood, cervix, and stool), bacterial strain tested: e.Coli etc., bacteria detected: none].C-reactive protein - on (b)(6) 2018: 0.2; on (b)(6) 2018: 0.62 [h]; on (b)(6) 2018: 22.97 [h]; on (b)(6) 2018: 17.21 [h]; on (b)(6) 2018: 14.66 [h]; on (b)(6) 2018: 12.65 [h]; on (b)(6) 2018: 16.98 [h]; on (b)(6) 2018: 17.90 [h]; on (b)(6) 2018: 15.32 [h]; on (b)(6) 2018: 10.50 [h]; on (b)(6) 2018: 8.57 [h]; on (b)(6) 2018: 2.44 [h]; on (b)(6) 2018: 0.81 [h]; on (b)(6) 2018: 0.26 computerised tomogram - on (b)(6) 2018: [no noteworthy findings in pharynx and larynx no pathological lymph nodes enlarged.No noteworthy findings in scanned area of the head.Chest: no nodular lesion or consolidation mediastinum: no cardiomegaly or pathological lymph nodes enlarged no pleural effusion was noted.Post caesarean section: no pneumatosis in operated lesion around the uterus.Intra-abdominal absorption value of fat tissue generally increased.Considering postoperative alterations.Uterine enlargement was noted.Ascites was noted.Digestive tract: diffuse thickening of the colon wall was noted.Fluid collection in the rectum was noted.Liver: smooth surface, sharp margin.Water absorption nodule sized 4 mm was noted in s8.No noteworthy findings in the bile, pancreas, spleen, adrenal gland, kidney and urinary tract.Enterocolitis was suspected.]; on (b)(6) 2018: [[findings] post caesarean section pneumatosis in operated lesion around the uterus decreased.Intra-abdominal absorption value of fat tissue generally increased.Ascites apparently increased.Thickening of peritoneum was noted.Fat tissue in omentum area showed heterogeneously increased absorption levels, which aggravated.Uterine enlargement was noted.This time, low-density area sized 33 x 25 mm was found in left uterine wall and gas was generated inside.Ascites was noted.Fluid collection sized 30 mm was noted in left pelvic floor.No marked change from the last time.Digestive tract: diffuse thickening of the colon wall was noted.Fluid collection in the rectum was noted.Liver: smooth surface, sharp margin.Water absorption nodule sized 4 mm was noted in s8.No noteworthy findings in the bile, pancreas, spleen, adrenal gland, kidney and urinary tract.No abnormal findings de novo in scanned area in the lung field.[diagnosis] post caesarean section ascites retention, uterine enlargement.=> ascites volume apparently increased.Aggravation of thickening of peritoneum and increased absorption levels in omentum area => condition of peritonitis was presumed.] eosinophil count - on (b)(6) -2018: 16 [l]; on -(b)(6) 2018: [0(l)]; on (b)(6) 2018: 168; on (b)(6) 2018: 52 [l]; on (b)(6) 2018: 23 [l]; on (b)(6) 2018: 28 [l]; on (b)(6) 2018: 25 [l]; on (b)(6) -2018: 133 [l]; on (b)(6) 2018: 93 [l]; on (b)(6) -2018: 69 [l]; on (b)(6) 2018: 61 haemoglobin - on (b)(6) 2018: 13.3; on (b)(6) 2018: 9.4 [9.4(l) 6.4(l) 10.3]; on (b)(6) 2018: 8.7 [l]; on (b)(6) 2018: 8.8 [l]; on (b)(6) 2018: 7.9 [l]; on (b)(6) 2018: 8.0 [l]; on (b)(6) 2018: 7.1 [l]; on (b)(6) 2018: 8.2 [l]; on (b)(6) 2018: 7.8 [l]; on (b)(6) -2018: 7.9 [l]; on (b)(6) 2018: 7.6 [l]; on (b)(6) 2018: 8.1 [l]; on (b)(6) 2018: 7.7 [l]; on (b)(6) 2018: 9.1 [l] neutrophil count - on (b)(6) 2018: 89.3 [h]; on (b)(6) 2018: 83.0 [h]; on (b)(6) 2018: 75.0 [h]; on (b)(6) 2018: 90.3 [h]; on (b)(6) 2018: 90.0 [h]; on (b)(6) 2018: 83.4 [h]; on (b)(6) 2018: 88.9 [h]; on (b)(6) 2018: 76.3 [h]; on (b)(6) 2018: 77.7 [h]; on (b)(6) 2018: 74.5 [h]; on (b)(6) -2018: 70.0 white blood cell count - on (b)(6) 2018: 19.8 [h]; on (b)(6) 2018: 14.2 [14.2(h) 17.4(h) 15.7(h)]; on(b)(6) 2018: 16.3 [h]; on (b)(6) 2018: 8.3; on (b)(6) 2018: 9.2 [h]; on (b)(6) 2018: 8.4; on (b)(6) 2018: 17.4 [h]; on (b)(6) 2018: 11.5 [h]; on (b)(6) 2018: 9.3 [h]; on (b)(6) 2018: 12.6 [h]; on (b)(6) 2018: 7.4; on (b)(6) 2018: 5.8; on (b)(6) 2018: 6.3; on (b)(6) 2018: 6.1.Final diagnosis was severe peritonitis (site of onset: cervix).The patient was treated with amoxicillin, clavulanic acid (augmentin [amoxicillin;clavulanic acid]), azithromycin (zithromac), ceftriaxone sodium hydrate (ceftriaxone sodium hydrate), metronidazole (anaemetro) and levofloxacin (levofloxacin hydrate).The patient outcome is reported as recovered / resolved on 19-sep-2018 for peritonitis (site of onset: cervix), as recovered / resolved on 19-sep-2018 for pyrexia and as recovered / resolved on 19-sep-2018 for abdominal pain.Additionally, at time of reporting, the patient delivered a baby on (b)(6) 2018 (delivery type: cesarean).Outcome of the pregnancy was reported as live birth (nos) and fetal outcome was reported as fetal defect.Reporter comment: positional relationship between site of onset and applied site of seprafilm: apparently identical.The causal relationship between seprafilm and peritonitis (site of onset: cervix): unknown (difficult to be assessed, no pathological proof).Possible causative factors for peritonitis (site of onset: cervix) other than seprafilm: the patient's risk factors (premature rupture of membranes, full cervical dilation, emergency caesarean section).The reporter's comment on peritonitis (site of onset: cervix): blood test results were confirmed during the surgery, but were from just after rupture of membranes.In the most recent blood test before the surgery, wbc was 19800 and crp was 0.62, suggesting increased levels.Tissue disorder and others were possible as the cervix was fully dilated.Meanwhile, infection was also possible as vagina was reachable during the surgery and membranes were already ruptured.No bacteria were detected as antibiotic was used.Yet, white moss was markedly adhered at the site where seprafilm was applied.Hence, it was considered that the use of anti-adhesion barriers should be avoided in the cases that preoperative antibiotic administration was insufficient due to extremely urgent caesarean section following rupture membranes and full cervical dilation and that infection was indicated.Additional information was received on 11-apr-2019: investigation summary was received (investigation summary #(b)(6), event id: (b)(4)).Added the company comment.Correction to the previous report: added date implanted in production information.Additional information was received on 06-aug-2019 from the physician: added "pyrexia" and "abdominal pain" as symptoms of the event; deleted "abscess (site of onset: cervix)" from the adverse events; updated reporter information, patient information (birthdate, height, and weight), and other relevant history; changed pregnancy from "no" to "yes" and added pregnancy information; added laboratory data, concomitant drugs, and treatment drugs; updated medical causality assessed by sanofi, information on the event "peritonitis (site of onset: cervix)" (seriousness criteria, intensity, recovery date, and treatment received?); and updated clinical course and reporter comment.
|
